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The ATR Surgical Micromotors are intended to prepare intraoral bone for implantology procedures.

The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.

The provided text describes a medical device submission (510(k)) for the ATR Surgical Micromotors. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving the device meets those criteria.

Here's an analysis of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the text. The document states: "The ATR Surgical Micromotors were subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the ATR Surgical Micromotors conformed to applicable emission, immunity and electromagnetic compatibility standards in accordance with EN and IEC regulations. Results of the testing showed that the ATR Surgical Micromotors perform as intended."

This is a summary statement that mentions testing against standards but does not list specific acceptance criteria (e.g., "torque must be within X +/- Y Nm") nor does it provide quantitative results for each criterion. It only gives a general conclusion that the device "perform[s] as intended."

2. Sample Size Used for the Test Set and Data Provenance

Not provided in the text. The document mentions "performance bench testing" and "physical performance studies" but does not specify the sample size of devices tested or any data provenance (e.g., country of origin, retrospective/prospective). This is typical for bench testing where the 'sample' might refer to the number of units tested, but it's not detailed here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/provided in the text. Ground truth is usually established for studies involving human interpretation or clinical outcomes. This document describes bench testing of a mechanical device (surgical micromotor), not a diagnostic or AI-driven system that would require expert-established ground truth for its performance evaluation.

4. Adjudication Method for the Test Set

Not applicable/provided in the text. See #3. Adjudication methods (like 2+1, 3+1) are relevant when multiple experts provide opinions on data (e.g., images), and a consensus is needed to establish ground truth for evaluating an AI or diagnostic tool. This is not the type of study described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC study was NOT done. This type of study would compare human readers' performance with and without AI assistance. The ATR Surgical Micromotors are a mechanical device for surgery, not an AI-driven diagnostic or interpretative tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. The device is a surgical micromotor, not an algorithm. The performance described is of the physical device itself.

7. The Type of Ground Truth Used

Given the nature of the device (a surgical micromotor), the "ground truth" for its performance would be established by engineering specifications, physical measurements, and compliance with industry standards (e.g., EN and IEC regulations). The text states it "conformed to applicable emission, immunity and electromagnetic compatibility standards" and "perform[s] as intended" based on these bench tests.

8. The Sample Size for the Training Set

Not applicable/provided in the text. Training sets are used for machine learning algorithms. The ATR Surgical Micromotors are a microprocessor-driven mechanical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. See #8.

In summary, the provided document focuses on establishing substantial equivalence for a physical medical device (a surgical micromotor) through bench testing against industry standards, rather than evaluating an AI or diagnostic tool that would involve ground truth established by experts, MRMC studies, or training sets.

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